| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Physical Activity Multiple Myeloma Quality of Life | Behavioral: Physical exercises Behavioral: Optional physical exercises | Not Applicable |
Physical exercises program is known to improve quality of life, chronical fatigue and appears to be a behavioural recommendation against cancer as primary and tertiary prevention. Nutritional status is also important in cancer patients: a loss of 5% of weight increases the complication risks and decreases survival and the quality of life. Interactions between physical activity and haematological malignancies are less described compared to solid cancers. This multicentre project is a randomised study versus controlled group that evaluates supervised physical exercises program in a homogenous population: patients under-65-years-old with multiple myeloma and who will undergo autologous stem cell transplantation. The hypothesis of this study is that a supervised physical exercises program during and after autograft might have a positive impact on the physical capacities and the quality of life.
In the experimental arm, patients will benefit regularly from a physical exercises program during their hospitalization. When going back home, they will be given a practical help kit with specific equipment (dumbbell, elastic), an actimeter with heart rate monitoring (in order to have an objective collection of the physical practice in addition to a self-evaluation) and a physical exercises program on paper and video supports, that patients would have learnt during their hospitalization. Furthermore, SMS will be regularly sent to remind them to practice. In the controlled arm, patients will be hospitalized in the same conditions than the experimental group and can practice if they want. At the end of the hospitalization, they will receive a paper document with global informations about physical exercises including a few simple exercises. Evaluations will be carried out in both arms at day 0, day 30 and day 90 from autograft. The post graft follow up will be done at the same time as the medical consultation and before the maintenance treatment.
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 100 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Supportive Care |
| Official Title: | Physical Exercises for Patient Undergoing Hematopoietic Stem Cell Transplantation for Multiple Myeloma: a Controlled Randomised Prospective Multicentre Longitudinal Study. |
| Estimated Study Start Date : | May 2019 |
| Estimated Primary Completion Date : | May 2021 |
| Estimated Study Completion Date : | August 2021 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: Physical exercise arm
patients will benefit regularly from a physical exercises program during their hospitalization. When going back home, they will be given a practical help kit with specific equipment (dumbbell, elastic), an actimeter with heart rate monitoring (in order to have an objective collection of the physical practice in addition to a self-evaluation) and a physical exercises program on paper and video supports, that patients would have learnt during their hospitalization. Furthermore, SMS will be regularly sent to remind them to practice
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Behavioral: Physical exercises
patients will benefit regularly from a physical exercises program during their hospitalization. When going back home, they will be given a practical help kit with specific equipment (dumbbell, elastic), an actimeter with heart rate monitoring (in order to have an objective collection of the physical practice in addition to a self-evaluation) and a physical exercises program on paper and video supports, that patients would have learnt during their hospitalization.
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Active Comparator: controlled arm
patients will be hospitalized in the same conditions than the experimental group and will be able to practice if they want.
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Behavioral: Optional physical exercises
patients will be proposed for the physical exercises and will practice them if they want.
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The quality of life will be measure with the QLQ-MY20 questionnaire to assess the quality of life of cancer patients.
QLQ-MY20 domain scores are averaged and transformed linearly to a score ranging from 0-100. A high score for Disease Symptoms and Side Effects of Treatment represents a high level of symptomatology or problems, whereas a high score for Future Perspective and Body Image represents better outcomes.
The quality of life will be measure with the QLQ-MY20 questionnaire to assess the quality of life of cancer patients.
QLQ-MY20 domain scores are averaged and transformed linearly to a score ranging from 0-100. A high score for Disease Symptoms and Side Effects of Treatment represents a high level of symptomatology or problems, whereas a high score for Future Perspective and Body Image represents better outcomes.
The quality of life will be measure with the QLQ-MY20 questionnaire to assess the quality of life of cancer patients.
QLQ-MY20 domain scores are averaged and transformed linearly to a score ranging from 0-100. A high score for Disease Symptoms and Side Effects of Treatment represents a high level of symptomatology or problems, whereas a high score for Future Perspective and Body Image represents better outcomes.
| Ages Eligible for Study: | 18 Years to 65 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
| Contact: Marie Beaumont, MD | (33)322455914 | beaumont.marie@chu-amiens.fr | |
| Contact: Quentin Vacandare, Pr | (33)322456443 | vacandare.quentin@chu-amiens.fr |
| Principal Investigator: | caroline delette, MD | CHU Amiens | |
| Principal Investigator: | Pierre Morel, MD | CHU Amiens | |
| Principal Investigator: | Fabrice Jardin, Pr | CHU Rouen | |
| Principal Investigator: | Oana Brehar, MD | CHU Rouen | |
| Principal Investigator: | Vincent Camus, MD | CHU Rouen | |
| Principal Investigator: | Nathalie Cardinael, MD | CHU Rouen | |
| Principal Investigator: | Nathalie Contentin, MD | CHU Rouen | |
| Principal Investigator: | Marie-Laure Fontoura, MD | CHU Rouen | |
| Principal Investigator: | Carole Fronville Varnier, MD | CHU Rouen | |
| Principal Investigator: | Hélène Lanic, MD | CHU Rouen | |
| Principal Investigator: | Emilie Lemasle Hue, MD | CHU Rouen | |
| Principal Investigator: | Pascal Lenain, MD | CHU Rouen | |
| Principal Investigator: | Stéphane Lepretre, MD | CHU Rouen | |
| Principal Investigator: | Anna-Lise Menard, MD | CHU Rouen | |
| Principal Investigator: | Aspasia Stamatoullas-Bastard, MD | CHU Rouen | |
| Principal Investigator: | Hervé Tilly, MD | CHU Rouen | |
| Principal Investigator: | Gandhi L Damaj, Pr | CHU Caen | |
| Principal Investigator: | Stéphane Cheze, MD | CHU Caen | |
| Principal Investigator: | Margaret Macro, MD | CHU Caen |
| Tracking Information | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| First Submitted Date ICMJE | May 9, 2019 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| First Posted Date ICMJE | May 10, 2019 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Last Update Posted Date | May 17, 2019 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Estimated Study Start Date ICMJE | May 2019 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Estimated Primary Completion Date | May 2021 (Final data collection date for primary outcome measure) | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Current Primary Outcome Measures ICMJE |
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| Original Primary Outcome Measures ICMJE |
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| Change History | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE |
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| Current Other Pre-specified Outcome Measures | Not Provided | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Original Other Pre-specified Outcome Measures | Not Provided | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Descriptive Information | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Brief Title ICMJE | Physical Activity for Myeloma Autograft Longitudinal Study | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Official Title ICMJE | Physical Exercises for Patient Undergoing Hematopoietic Stem Cell Transplantation for Multiple Myeloma: a Controlled Randomised Prospective Multicentre Longitudinal Study. | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Brief Summary | Physical exercises program is known to improve quality of life, chronical fatigue and appears to be a behavioural recommendation against cancer as primary and tertiary prevention. Nutritional status is also important in cancer patients: a loss of 5% of weight increases the complication risks and decreases survival and the quality of life. Interactions between physical activity and haematological malignancies are less described compared to solid cancers. Methodology and protocols are also heterogeneous. Supervised exercises program improves the physical condition and the quality of life; however there are few randomised studies versus a controlled group. Post autograft evaluation for myeloma patients showed a physical deficit with increased fat mass, but in this particular population physical exercises need to be more explored. This project is a randomised study versus controlled group that evaluates supervised physical exercises program in a homogenous population: patients under-65-years-old with multiple myeloma and who will undergo autologous stem cell transplantation. | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Detailed Description |
Physical exercises program is known to improve quality of life, chronical fatigue and appears to be a behavioural recommendation against cancer as primary and tertiary prevention. Nutritional status is also important in cancer patients: a loss of 5% of weight increases the complication risks and decreases survival and the quality of life. Interactions between physical activity and haematological malignancies are less described compared to solid cancers. This multicentre project is a randomised study versus controlled group that evaluates supervised physical exercises program in a homogenous population: patients under-65-years-old with multiple myeloma and who will undergo autologous stem cell transplantation. The hypothesis of this study is that a supervised physical exercises program during and after autograft might have a positive impact on the physical capacities and the quality of life. In the experimental arm, patients will benefit regularly from a physical exercises program during their hospitalization. When going back home, they will be given a practical help kit with specific equipment (dumbbell, elastic), an actimeter with heart rate monitoring (in order to have an objective collection of the physical practice in addition to a self-evaluation) and a physical exercises program on paper and video supports, that patients would have learnt during their hospitalization. Furthermore, SMS will be regularly sent to remind them to practice. In the controlled arm, patients will be hospitalized in the same conditions than the experimental group and can practice if they want. At the end of the hospitalization, they will receive a paper document with global informations about physical exercises including a few simple exercises. Evaluations will be carried out in both arms at day 0, day 30 and day 90 from autograft. The post graft follow up will be done at the same time as the medical consultation and before the maintenance treatment. |
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| Study Type ICMJE | Interventional | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Study Phase ICMJE | Not Applicable | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Supportive Care |
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| Condition ICMJE |
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| Intervention ICMJE |
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| Study Arms ICMJE |
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| Publications * | Not Provided | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Recruitment Status ICMJE | Not yet recruiting | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Estimated Enrollment ICMJE |
100 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Original Estimated Enrollment ICMJE | Same as current | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Estimated Study Completion Date ICMJE | August 2021 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Estimated Primary Completion Date | May 2021 (Final data collection date for primary outcome measure) | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender ICMJE |
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| Ages ICMJE | 18 Years to 65 Years (Adult, Older Adult) | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Accepts Healthy Volunteers ICMJE | No | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Contacts ICMJE |
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| Listed Location Countries ICMJE | Not Provided | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Removed Location Countries | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Administrative Information | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| NCT Number ICMJE | NCT03946332 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Study ID Numbers ICMJE | 2018_A00307_48 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Has Data Monitoring Committee | No | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement ICMJE |
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| Responsible Party | Centre Hospitalier Universitaire, Amiens | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Study Sponsor ICMJE | Centre Hospitalier Universitaire, Amiens | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Collaborators ICMJE |
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| Investigators ICMJE |
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| PRS Account | Centre Hospitalier Universitaire, Amiens | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Verification Date | May 2019 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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